Country: United States
Language: English
Source: NLM (National Library of Medicine)
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
Preferred Pharmaceuticals, Inc
LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 100 mg
ORAL
PRESCRIPTION DRUG
Losartan potassium tablets USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. Losartan potassium tablets USP are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, Losartan potassium tablets, USP reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). Losartan potassium is contraindicated in patients who are hypersensitive to any component of this product. Do not co-administer aliskiren with Losartan potassium in patients with diabetes. Read the Patient Information that comes with Losartan potassium tablets before you start taking it and each ti
Losartan potassium tablets USP, 100 mg, are white to off-white, round, convex, beveled edge, film-coated tablets, debossed with HH on one side and 113 on the other side. They are supplied as follows: Store at 20 to 25°C (68 to 77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang, 317024, China Distributed by: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 Revised: 10/2015 07191-06 Repackaged By: Preferred Pharmaceuticals, Inc.
Abbreviated New Drug Application
LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET, FILM COATED PREFERRED PHARMACEUTICALS, INC ---------- LOSARTAN POTASSIUM TABLETS, USP, FOR ORAL USE RX ONLY WARNING: FETAL TOXICITY • • DESCRIPTION Losartan potassium is an angiotensin II receptor (type AT ) antagonist. Losartan potassium, a non- peptide molecule, is chemically described as 2-butyl-4-chloro-1-[_p_-(_o-1H_-tetrazol-5- ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Losartan potassium USP is a white to off-white free-flowing crystalline powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, magnesium stearate, hydroxypropyl cellulose, hypromellose and titanium dioxide. Losartan potassium tablets, USP, 25 mg, 50 mg and 100 mg, contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. Losartan potassium When pregnancy is detected, discontinue Losartan potassium as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity. 1 Its empirical formula is C H ClKN O, and its structural formula is: 22 22 6 tablets USP, 25 mg and 50 mg meet USP Dissolution Test 1 and Losartan potassium tablets USP, 100 mg meet USP dissolution Test 3. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)], is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the Read the complete document